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Reporting Scenario # 1 PowerPoint PPT Presentation

Reporting Scenario # 1. September 18, 2005. Scenario # 1. A pancreas is used to prepare islets under IND. The donor was a victim in a motor vehicle accident. The accompanying records (including donor eligibility determination) are complete. The pancreas appears in good condition.

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Reporting Scenario # 1

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Scenario # 1

No (but after the product is licensed, this would be considered a reportable biological product deviation).

Scenario # 1

If an adverse event, is the event serious?

Not applicable, no AE occurred.

Scenario # 1

Is this reportable to the FDA? If so, how should it be reported?

This is not reportable as an IND safety report. However, it should be documented in your records and included in IND annual report.

Scenario # 1

What else should you do?

Follow up with the OPO to obtain results of the drug screen.

It would be prudent to

Notify the recipient’s physician

Follow the patient for seroconversion

Scenario # 1

If the information was available before the islets were infused, could the physician use the product? Could he/she invoke Urgent Medical Need?

Use of the product depends on whether you interpret the donor screening results as meeting the Donor Eligibility criteria, and this depends on trying to get more information before the product needs to be released. While you have a report of drug paraphernalia in the car, you don’t have any hard evidence that the donor actually engaged in risk behavior– so this is a very difficult judgment call.

Urgent medical need should only be invoked when the patient has extremely limited clinical treatment options and other products are not available.